Protocol summary
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Study aim
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The aim of this study is to determine the effects of probiotic supplementation on levels of gene expression related with glycemic control, lipid and inflammatory factors in in patients with multiple sclerosis.
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Design
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Parallel double-blind (both patients and researchers) randomized controlled clinical trial
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Settings and conduct
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40 patients with multiple sclerosis of eligible and referred to Beheshti Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected
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Participants/Inclusion and exclusion criteria
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Patients with multiple sclerosis and aged 18 to 55 years will be included in this study. The participants will be excluded from the study under following conditions: women who were pregnant or lactating during the past six months, taking probiotic or synbiotic products, menopaused women with irregular menstruation and unwillingness to utilize appropriate contraceptive tools.
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Intervention groups
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Patients will be assigned to receive either probiotic (n=20) or placebo (n=20).
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Main outcome variables
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Levels of gene expression related with glycemic control, lipid and inflammatory factors
General information
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Reason for update
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The updating process was done after publishing the paper to correct the registration information.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201609185623N88
Registration date:
2016-09-27, 1395/07/06
Registration timing:
retrospective
Last update:
2023-04-03, 1402/01/14
Update count:
2
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Registration date
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2016-09-27, 1395/07/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Kashan University of Medical Sciences
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Expected recruitment start date
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2016-07-24, 1395/05/03
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Expected recruitment end date
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2016-07-31, 1395/05/10
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Clinical trial of the effect of probiotic supplementation compared with the placebo on levels of gene expression related with glycemic control, lipid and inflammatory factors in patients with multiple sclerosis
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Public title
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Effect of supplementation in treatment of patients with multiple sclerosis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with multiple sclerosis
Aged 18 to 55 years
Course of disease relapsing–remitting MS (RRMS)
EDSS ≤4.5
Exclusion criteria:
Pregnancy
Women who were lactating within the prior six month
Consumption of of probiotic or synbiotic
Menopaused women with irregular menstruation
Unwillingness to utilize appropriate contraceptive tools
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Age
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From 18 years old to 55 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either probiotic supplements (n = 20) or placebo (n = 20). Randomization will be done by the use of computer-generated random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Shahid Beheshti Clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-07-23, 1395/05/02
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Ethics committee reference number
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IR.Kaums.REC.1395.42
Health conditions studied
1
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Description of health condition studied
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Multiple sclerosis
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ICD-10 code
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G35
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ICD-10 code description
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Multiple sclerosis
Primary outcomes
1
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Description
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Tumor necrosis factor alpha
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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PCR
2
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Description
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Interleukin 1
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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PCR
3
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Description
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Interleukin-8
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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PCR
Secondary outcomes
1
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Description
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Peroxisome proliferator–activated receptor γ (PPARγ)
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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PCR
2
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Description
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Low Density Lipoprotein Receptor (LDLR)
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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PCR
Intervention groups
1
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Description
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Control group: Placebo (Barij Essence, Kashan, Iran), daily, for 12 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: Probiotic capsule containing four strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g), Bifidobacterium bifidum (2×109 CFU/g) and Lactobacillus fermentum (2×109 CFU/g) (Tak Gen Zist, Tehran, Iran), daily, for 12 weeks orally.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available